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Sunday, August 12, 2018 4:53:12 PM
505(b)(2) is particularly valuable for pharmaceutical and generics companies looking to alleviate competitive forces in their environments while still wanting to benefit from a development process that eliminates most nonclinical studies as well as extensive safety and efficacy tests.
Relatively low risk because of previous drug approval
Lower cost, accelerated development due to fewer studies
May qualify for three, five or seven years of market exclusivity............
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